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Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Elderly

Primary Purpose

Influenza

Status

Recruiting

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

GPO Tri Fluvac vaccine

Licensed influenza vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza Vaccine, Tri Fluvac vaccine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age ≥ 65 years old on the day of screening, having Thai ID card or equivalent
Able to read and write in Thai and sign written informed consent form
Able to attend all scheduled visits and to comply with all trial procedures.
Healthy or medically stable, as established by medical history and physical examination. For individuals with medical conditions, symptoms/signs, if present must be stable, under control or unchanged for the past three months. If medication is used to treat the condition, the medication dose must have been stable for at least one month preceding vaccination.

Exclusion Criteria:

Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
Hypersensitivity after previous administration of any vaccine.
Having a history of H1N1, H3N2 or FluB infection within 3 months preceding enrollment to the trial
Vaccination against influenza in the past 6 months preceding enrollment to the trial
Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 28 visit.
History of bronchial asthma, chronic lung diseases, chronic rhinitis
History of immunodeficiency state
History of immunosuppression < 6 months prior to immunization
History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. egg proteins, gentamicin or thimerosal)
History of Guillain-Barré Syndrome or cerebrovascular events
Having acute infection with fever > 38 degree Celsius or noninfectious diseases (within 72 hours) preceding enrollment in the trial
Volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the trial or planned receipt of such products prior to the Day 28 visit.
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine
Study site employees who are involved in the protocol and/or may have direct access to study related area

Sites / Locations

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

GPO Tri Fluvac vaccine

Licensed Influenza vaccine

Arm Description

408 participants will receive a seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2020 (consisting of A/Brisbane/02/2018 (H1N1)pdm-09-like virus, A/South Australia/34/2019 (H3N2)-like virus, and B/Washington/02/2019-like (B/Victoria lineage) virus) produced by the Government Pharmaceutical Organization (GPO), Thailand. The vaccine to be administered by intramuscular (IM) injection.

408 will receive a Licensed Influenza vaccine (seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2020 (consisting of A/Brisbane/02/2018 (H1N1) pdm-09-like virus, A/South Australia/34/2019 (H3N2)-like virus, and B/Washington/02/2019-like (B/Victoria lineage) virus) 0.5 mL administered intramuscularly (IM) in the deltoid muscle of the non-dominant arm.

Outcomes

Primary Outcome Measures

Number and percentage of seroconverted participants at 28 days post vaccination

seroconversion is defined as a serum HI antibody titer meeting the following four fold rising criteria: Pre-vaccination titer <1:10 and a post-vaccination measured on Day 28 of ≥1:40; or Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 28.

Geometric Mean Titers (GMTs) of serum HI antibodies at baseline (Day 0) and post- vaccination (Day 28).

Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 28) for each of the three vaccine antigens. GMTs will be calculated with 95% CI.

Secondary Outcome Measures

Number and percentage of participants with solicited local and systemic adverse events. post vaccination

Solicited local adverse events including redness/erythema, swelling/induration, pain, and limitation of arm movement. Solicited systemic adverse events including fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, and headache.

Number and percentage of participants with unsolicited adverse event.

Number and percentage of participants with unsolicited adverse event occuring during the entire study period (Days 0-180)

Number and percentage of participants with serious adverse event.

Number and percentage of participants with serious adverse event occuring during the entire study period (Days 0-180)

Number and percentage of participants with HI response with and without pre-existing HI antibody.

Number and percentage of participants with a HI antibody titer ≥1:40 (seroprotective level) to each of the three vaccine antigens.

Full Information

NCT ID

NCT04548518

First Posted

August 17, 2020

Last Updated

August 23, 2022

Sponsor

Mahidol University

Collaborators

The Government Pharmaceutical Organization

1. Study Identification

Unique Protocol Identification Number

NCT04548518

Brief Title

Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Elderly

Official Title

A Phase III Double Blinded, Randomized, Controlled, Non-inferiority Trial to Evaluate the Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Subjects Aged 65 Years and Above

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 3, 2020 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

Collaborators

The Government Pharmaceutical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study is aim to evaluate the Immunogenicity with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine).

Detailed Description

This is a phase III, non-inferiority double-blinded, randomized, controlled trial of immunogenicity with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine). A total of about 816 healthy Thai male and female adult volunteers ≥ 65 years of age; 408 participants will be randomized to receive the GPO Tri Fluvac and 408 will receive an active comparator (a 1:1 ratio).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza Vaccine, Tri Fluvac vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

non-inferiority double-blinded, randomized, controlled trial

Masking

ParticipantInvestigator

Masking Description

double blinded

Allocation

Randomized

Enrollment

816 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GPO Tri Fluvac vaccine

Arm Type

Active Comparator

Arm Description

Arm Title

Licensed Influenza vaccine

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

GPO Tri Fluvac vaccine

Intervention Description

Each dose of Tri Fluvac contains a total of 45 micrograms (μg) hemagglutinin (HA) per 0.5 ml dose (15 μg HA per strain per dose), to be administered by intramuscular (IM) injection. Tri Fluvac is manufactured and formulated into a multiple-dose vial vaccine (2 doses) using thimerosal at relatively low concentration as preservative (≤ 5.75 μg mercury/ dose). Each 0.5 ml dose of vaccine may contain residual amounts of ovalbumin (≤ 1.0μg), formaldehyde (≤ 100μg), tween 80 (≤ 0.9μg), triton x-100 (≤0.05μg) and gentamicin (≤0.075μg).

Intervention Type

Biological

Intervention Name(s)

Licensed influenza vaccine

Intervention Description

The comparator licensed influenza vaccine is a seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2020

Primary Outcome Measure Information:

Title

Number and percentage of seroconverted participants at 28 days post vaccination

Description

Time Frame

28 days

Title

Geometric Mean Titers (GMTs) of serum HI antibodies at baseline (Day 0) and post- vaccination (Day 28).

Description

Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 28) for each of the three vaccine antigens. GMTs will be calculated with 95% CI.

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Number and percentage of participants with solicited local and systemic adverse events. post vaccination

Description

Time Frame

30 minutes, Day 1-3 post-vaccination

Title

Number and percentage of participants with unsolicited adverse event.

Description

Number and percentage of participants with unsolicited adverse event occuring during the entire study period (Days 0-180)

Time Frame

180 days

Title

Number and percentage of participants with serious adverse event.

Description

Number and percentage of participants with serious adverse event occuring during the entire study period (Days 0-180)

Time Frame

180 days

Title

Number and percentage of participants with HI response with and without pre-existing HI antibody.

Description

Number and percentage of participants with a HI antibody titer ≥1:40 (seroprotective level) to each of the three vaccine antigens.

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 65 years old on the day of screening, having Thai ID card or equivalent Able to read and write in Thai and sign written informed consent form Able to attend all scheduled visits and to comply with all trial procedures. Healthy or medically stable, as established by medical history and physical examination. For individuals with medical conditions, symptoms/signs, if present must be stable, under control or unchanged for the past three months. If medication is used to treat the condition, the medication dose must have been stable for at least one month preceding vaccination. Exclusion Criteria: Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study. Hypersensitivity after previous administration of any vaccine. Having a history of H1N1, H3N2 or FluB infection within 3 months preceding enrollment to the trial Vaccination against influenza in the past 6 months preceding enrollment to the trial Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 28 visit. History of bronchial asthma, chronic lung diseases, chronic rhinitis History of immunodeficiency state History of immunosuppression < 6 months prior to immunization History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. egg proteins, gentamicin or thimerosal) History of Guillain-Barré Syndrome or cerebrovascular events Having acute infection with fever > 38 degree Celsius or noninfectious diseases (within 72 hours) preceding enrollment in the trial Volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the trial or planned receipt of such products prior to the Day 28 visit. Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine Study site employees who are involved in the protocol and/or may have direct access to study related area

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Punnee Pitisuttithum

Phone

(662) 6435599

punnee.pit@mahidol.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Punnee Pitisuttithum

Organizational Affiliation

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

City

Bangkok

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Punnee Pitisuttithum

Phone

6626435599

punnee.pit@mahidol.ac.th

First Name & Middle Initial & Last Name & Degree

Punnee Pitisuttithum

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Elderly

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